The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses.

The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.

No use of oral contraceptives, depot-medroxyprogesterone acetate, contraceptive ring or patch within two months of screening

No cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use

Has used raltegravir prior to screening

Has no history of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer)

Must not have had an abnormal pap test defined without resolution in the last 18 months.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597180

Locations

United States, North Carolina

UNC Infectious Disease Clinic

Chapel Hill, North Carolina, United States, 27516

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Merck Sharp & Dohme Corp.

Investigators

Principal Investigator:

Gretchen S Stuart, MD

University of North Carolina, Chapel Hill

More Information

No publications provided

Responsible Party:

Gretchen Stuart, MD, Associate Professor, Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill